Background and Purpose-Adequate outcome assessment is crucial to randomized trials. We wished to assess the types of outcomes used in acute stroke trials and the appropriateness of these outcomes and their analyses. Methods-Acute stroke trials from the Cochrane Stroke Group's database were included from 1955 to 1995 if they were published in full text in English. For each trial we collected year of publication, number of patients randomized, blinding of outcome assessment, the specific outcome instruments used, the statistical methods used for analysis, and the significance of the results. The validity and reliability of each outcome measure were assessed by review of the literature. Results-Our study included 174 trials. Outcomes were assessed blindly in 69%. Death was recorded in only 76% of trials, impairment in 76%, disability in 42%, and handicap or quality of life in only 2%. Of the trials that measured impairment, 35% used a measure of established validity or reliability. For disability and handicap, the proportions with valid or reliable measures were 70% and 25%, respectively. Impairment and handicap measures were primarily analyzed as continuous variables, while disability was mainly analyzed as a dichotomous variable. Continuous data were usually analyzed with inappropriate parametric statistics. There was no relationship between the method of analysis, the type of outcome, and the statistical significance of results. Conclusions-Most

Introduction: Stroke is characterized by deleterious oxidative stress. Selenoprotein enzymes are essential endogenous antioxidants, and detailed insight into their role after stroke could define new therapeutic treatments. This systematic review aimed to elucidate how blood selenoprotein concentration and activity change in the acute phase of stroke. Methods: We searched PubMed, EMBASE, and Medline databases for studies measuring serial blood selenoprotein concentration or activity in acute stroke patients or in stroke patients compared to non-stroke controls. Meta-analyses of studies stratified by the type of stroke, blood compartment, and type of selenoprotein measurement were conducted. Results: Eighteen studies and data from 941 stroke patients and 708 non-stroke controls were included in this review. Glutathione peroxidase (GPx) was the only identified selenoprotein, and its activity was most frequently measured. Results from 12 studies and 693 patients showed that compared to non-stroke controls in acute ischaemic stroke patients, the GPx activity increased in haemolysate (standardized mean difference [SMD]: 0.27, 95% CI: 0.07–0.47) but decreased in plasma (mean difference [MD]: −1.08 U/L, 95% CI: −1.94 to −0.22) and serum (SMD: −0.54, 95% CI: −0.91 to −0.17). From 4 identified studies in 106 acute haemorrhagic stroke patients, the GPx activity decreased in haemolysate (SMD: −0.40, 95% CI: −0.68 to −0.13) and remained unchanged in plasma (MD: −0.10 U/L, 95% CI: −0.81 to 0.61) and serum (MD: −5.00 U/mL, 95% CI: −36.17 to 26.17) compared to non-stroke controls. Results from studies assessing the GPx activity in the haemolysate compartment were inconsistent and characterized by high heterogeneity. Conclusions: Our results suggest a reduction of the blood GPx activity in acute ischaemic stroke patients, a lack of evidence regarding a role for GPx in haemorrhagic stroke patients, and insufficient evidence for other selenoproteins.